Questions about the new AI health rules

PROGRAMMING NOTE: Well, off next week for the holidays but back to our normal schedule on Tuesday, Jan. 2.

With Megan R. Wilson

AI REG REACTION HHS has new rules set to take effect in 2025 that require artificial intelligence developers to disclose more about how their algorithms work, Ben reports.

There is industry support, but Pulse also heard skepticism about how effective the rules will be and questions about accountability and coverage.

The backstory: The Office of the National Coordinator for Health IT issued sweeping rules last week for AI used in most hospitals and doctors’ offices. In other words, the ONC regulations will require software developers to provide more data to customers to help providers determine whether AI products are fair, appropriate, valid, effective and safe.

The reaction: Major groups including the Coalition for Health AI with members including Google, Microsoft and Duke Health praised the rules.

Putting some standards in place is really important, said Michael Pencina of Duke AI Health and the co-founder of the Pulse coalition. They found the right balance, for the most part, about putting things forward but not being too prescriptive.

Agency contact: However, there are questions about how ONC and the FDA, which also regulate AI-enabled medical devices, will work together. Cybil Roehrenbeck, executive director of the AI ​​Healthcare Coalition, told Pulse that she wants ONC to treat products already regulated by the FDA differently.

The FDA review should count for something, Roehrenbeck said.

The ONC said in its rule that it has worked with the FDA to align regulations to reduce the compliance burden for AI developers covered by both agencies’ rules.

Liability: Roehrenbeck said that ONC rules rely on individual clinicians to make calls about the trustworthiness of AI also raises liability concerns. ONC says those are outside the scope of its rule.

If a medical device fails, we know how to move through that process, Andrew Tomlinson, director of regulatory affairs at the American Health Information Management Association, told Pulse. We need to have the same process for AI.

And Roehrenbeck said he’s gotten some questions about what algorithms apply to the rules, and he’s hoping for more clarity.

The agency said the rule has a broad scope, covering models not directly involved in clinical decision-making that could affect the delivery of care, such as those that aid in supply chains.

An ONC spokeswoman said the agency appreciates robust public feedback and welcomes it further.

WELCOME TO OUR LAST EDITION OF THE PULSE FOR 2023. Thanks for your reading, feedback, and tips throughout the year! Back in 2024. Please keep sending your tips, scoops and feedback to [email protected] and [email protected] and follow @ChelseaCirruzzo and @_BenLeonard _.

NOW TO OURS PULSE CHECK PODCAST, Host Chelsea Cirruzzo talks with POLITICO health care reporter Daniel Payne about the ways artificial intelligence is already being used across the medical landscape and how regulators are responding.

GRAIL LOBBIES UP Cancer diagnostics company Grail has added to its lobbying roster in Washington, hiring high-powered lobbying firms BGR Group and Williams & Jensen to work on issues including Medicare coverage for cancer-detection tests. many cancers, reports Megan.

At BGR Group, Grail has a former top health aide to the ousted Speaker Kevin McCarthy (R-Calif.) Ryan Long in its corner. He provides both strategic counsel to the company and advocates on issues related to oncology and multi-cancer diagnostics and screening, according to the disclosures.

Long, who left Capitol Hill in October, has a one-year cooling off period during which he cannot lobby any members or staff in leadership offices but confirmed he is free to lobby the rest of the House and Senate, in addition to the Biden administration.

Alec Aramanda, who most recently served as Medicare staff for Republicans on the House Energy and Commerce Committee, is among the lobbyists on Williams and Jensen’s contract. The disclosure forms say the company will make a pair of charges that will allow Medicare to cover the tests that Grail is doing. Aramanda joined the company last month. He did not respond to a request for comment.

Biotech giant Illumina, which bought Grail in 2021, announced earlier this week that it was exiting the company following years of fighting antitrust regulators over the deal. According to recently released lobbying disclosures, the two companies have been working on Grail since December 1.

As Congress advances bipartisan legislation that helps ensure Medicare has the authority to cover multi-cancer early detection tests, Grail continues to educate the science and address barriers to access to screening. cancer, a company spokesman said in an email.

EYES ON THE PRIZE Lobbyists for business and consumer groups are planning multiple calls and meetings with lawmakers and staff in the first weeks of 2024 and are considering ad buys hoping to push for stricter disclosure requirements in insurers, pharmacy benefit managers, hospitals and other health facilities at the finish line , Megan reports.

Members and staff will be taking a break to enjoy time with their families, but they will start hearing from us again before they get back to Washington, said Adam Buckalew, a lobbyist representing Better Solutions for Healthcare, a coalition that includes of AHIP and the American Benefits Council.

Earlier this month, the House passed a sweeping health package that would expand Trump-era regulations that require hospitals and insurers to post their prices and negotiated rates for services and the Senate has indicated interest in moving the bill. Lawmakers in both chambers have advanced measures that would force pharmacy benefit managers who act as intermediaries between drugmakers and insurers to be more transparent about their business operations.

The measures are part of a year-long effort in Congress to address rising health care costs, an issue that could be particularly powerful in the 2024 election year.

NALOXONE IN FEDERAL BUILDINGS HHS and the General Services Administration, which oversees federal real estate, updated a nearly 15-year-old safety guide to say federal facilities must have naloxone, an opioid overdose-reversal that medicine, on site.

The updated guidance builds on 2009 recommendations that agencies have automated external defibrillators to treat people having heart attacks. The new guideline recommends that AED stations be turned into survival stations that also have naloxone and items to stop the bleeding.

RESPIRATORY DISEASE RELIEF VACATION Nearly 172,500 people went to the emergency room last week for the flu, Covid-19 or respiratory syncytial virus, according to CDC data.

Although the agency says the numbers are lower than it saw at the same time last year, they also indicate that the respiratory illness season, which usually lasts through the winter months, has not yet arrived.

According to CDC data, more than half of ER visits for the week ending Dec. 16 were for the flu and one-third were for Covid-19. RSV accounted for about 13 percent of visits. Most patients are children under 12 whose visits have been increasing since October.

However, vaccination rates remain low with less than half the population receiving a flu shot and less than 10 percent getting the latest Covid shot.

Nursing home residents, a vulnerable population that the CDC prioritizes in its vaccination campaign, have a slightly higher rate: As of Dec. 10, 33 percent of nursing residents had received the latest Covid shot.

Meanwhile, 17 percent of adults 60 and older have gotten their RSV shot.

The Government Accountability Office announced five new ones Health Information Technology Advisory Committee member: dr. Lee Fleisher of University of Pennsylvania School of Medicine, said Dr. Katrina Parrish of humane, said Dr. Randa Perkins of H. Lee Moffitt Cancer Center, Rochelle Prosser of Orchid Healthcare Solutions and Dr. Mark Sendak of Duke Institute for Health Innovation.

POLITICIAN Robert King reports on Congress’ decision to skip town without addressing a pending cut in physician Medicare payments, which could cause new headaches for practices and patients, according to physician groups that are demanding help from CMS.

The Washington Post reports of a puzzling increase in colon cancer among young people.

Dr. Zeke Emanuel, senior fellow at the Center for American Progressexplains to STAT why health costs are an exception to inflation.

CLARIFICATION: An earlier version of this newsletter was unclear about whether Alec Aramanda had any lobbying restrictions. He is not


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